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Completed NCT04798014

HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy

Conditions: Cystic Fibrosis

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Enrollment: 860
Sponsor: Indiana University

Location: Indiana University School of Medicine Indianapolis Indiana

Summary

This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enrolled through the Folia application. During the 12-month study period, participants will be asked to track their routine treatment and medication usage, daily symptoms, and monthly review with validated patient-reported outcome (PRO) questionnaires. Participants will also be asked to self-report instances of changes to their treatment plan, and pulmonary exacerbations. There are no study-associated site visits.

Eligibility Criteria

Inclusion Criteria: * Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian. * Is willing and able to adhere to protocol requirements. * ≥ 12 years of age at enrollment. * Diagnosed with CF. * Prescribed ETI for an on-label indication. * Participant has access to a mobile phone or tablet (iPhone or Android platform) or computer. * Participant has access to an internet connection. Exclusion Criteria: * Participant is enrolled in the randomized portion of the SIMPLIFY study (NCT04378153). * Participant does not have access to the necessary technology. * Participant is a recipient of a solid organ transplant (i.e. lung, liver, pancreas, kidney). * Participant cannot communicate in English.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04798014). StuddyBuddy aggregates publicly available trial information.